Quality Organization

Pharmacist Profession Program

Faculty of Pharmacy-Pancasila University
2016

ISO 9001:2015

Personnel
The establishment and maintenance
of a satisfactory system of quality
assurance and medicinal products
relies upon people. For the reason
there must be sufficient qualified
personnel to carry out all task which
are
the
responsibility
of
the
manufacturer.
(Chapter 2-CPOB, 2012)

Quality Organization
The conditions that underlie the achievement
of

high

performance

organizations are:
1. Creating recognition,
2. Generating confidence,
3. Developing fit,
4. Providing direction,
5. Building commitment.
James A. Belohlav, DePaul University

within

quality

Quality Organization

Creating Recognition
For any organization to exist, there must be
people who are willing to perform activities for
that organization-in other words, there must be
employees.
For a company to achieve high levels of
performance, the employees must not only
become a part of but also believe that they belong
to the organization.
A quality organization differs from most other
organizations because one of its primary activities
involves instilling a sense of belonging in all
employees.

Generating Confidence
The magnitude of confidence prevailing within
any organization is directly proportionate to the
amount of credibility and integrity that is present
in employees' actions.
Implementing an atmosphere of confidence
requires that support and feedback be present in
daily activities.
Within quality organizations, support means
helping employees produce a better product or
service for the customer and removing obstacles
that can interfere with getting work done
effectively.
Support and feedback create openness in the
organization. Openness enables employees to

Developing Fit
Productivity can only be increased when the
employees and the organization fit together.
To make a person fit, he or she must understand
what the organization is about, how it operates,
and what is important to its success.
Until the company can visualize what it wants to
achieve, every action has the same meaning.
Employees assume their roles as actors and
actresses in the corporate play to get their
paychecks so that they can do what they really
want to do.

Providing Directions
A company needs to send its charged-up
people in the right direction.
Setting people in the right direction is
accomplished through organizational focus.
Setting people in the right direction is usually
an easy endeavor since there is already a
point of reference from which to start.
Only employees who' are developed to their
full potential can see change as an
opportunity and take advantage of it.

Building Commitment
The final activity is, developing commitment in the
company. An important distinction must be made about this
stage:

Commitment

and

loyalty

are

related

but

not

synonymous. Loyalty is almost always present when there is

commitment, but the converse is not necessarily true. With
loyalty,

company

does

not

necessarily

get

high

performance. Only when there is commitment can the

highest levels of quality, productivity, and innovation be
achieved.

Building Commitment
A high level of commitment is evident in three
ways:
1. Typical organizational problems, such as
employee discipline or absenteeism, no longer
require major time and effort to resolve.
2. The organization is more creative. With
commitment,
individual
ownership
is
generated.

Building Commitment
3. Employees use their discretionary time-time that they

could be spending on other activities-working for the

organization because they are motivated to do so and
because they receive satisfaction from doing their jobs
and from being associated with the organization itself.
4. The secret of the quality organization is that it creates

not only high-performance processes or systems but

also values that underlie those processes and systems.

Sumber : Priyambodo,
2007

Pendahuluan
a)

Organisasi mutu melekat pada struktur organisasi

perusahaan.

b)

Fungsi manajemen mutu, penekanan kepada level

Top

Management.

Terutama

berkaitan

dengan

Kebijakan Mutu.
c)

Fungsi jaminan mutu, penekanan kepada bagian

Quality Assurance / Penjaminan Mutu (QA).

d)

Fungsi pengawasan mutu, penekanan kepada bagian

Quality Control / Pengawasan Mutu (QC).

Top Management
Pengambilan

kebijakan strategis dalam

perusahaan.
Fungsi

perencanaan secara luas

Mengelola
Presdir

seluruh sumber daya

(CEO) dan Plant Mgr

Sumber : Priyambodo,
2007

Penjaminan Mutu (QA)

Semua

aspek

yang

secara

kolektif

maupun individual mempengaruhi mutu

produk, dari konsep desain hingga produk
itu ditangan konsumen (WHO, 2004).
Tujuan :
o

Produk memenuhi persyaratan mutu.

Fokus kepada konsumen

Tugas Penjaminan Mutu

Complian

ce

Inspeksi
Inspeksi Diri,
Diri, Audit
Audit Mutu
Mutu dan
dan Audit
Audit Pemasok
Pemasok
Sistem
Sistem Dokumentasi
Dokumentasi
Pelatihan
Pelatihan
Pengelolan
Pengelolan Pengolahan
Pengolahan Ulang
Ulang

Pelulusan
Pelulusan Produk
Produk Jadi
Jadi
Keluhan,
Keluhan, Penarikan
Penarikan Produk
Produk dan
dan Produk
Produk
kembalian
kembalian
Pengelolaan
Pengelolaan Penyimpangan
Penyimpangan dan
dan Perubahan
Perubahan

PPQM

Validation

Validasi
Validasi
Kualifikasi
Kualifikasi &
& Kalibrasi
Kalibrasi
Studi
Studi Stabilitas
Stabilitas

Pengawasan Mutu (QC)

Quality control is the part of GMP concerned with :
a)

Sampling

b)

Specifications & testing

c)

Documentation

d)

Release Procedure

Quality control is not confined to laboratory operations, but

must be involved in all decisions concerning the quality of the
product.
The independence of quality from production is considered
fundamental.

Pengawasan Mutu
In Process Control (IPC)
Pengawasan selama proses produksi
Microbiology

Pelulusan Bahan Baku

Pelulusan Produk
Monitoring Lingkungan

Chemical Laboratory

Pemeriksaan Bahan Baku dan Bahan Kemas

Pemeriksaan Produk Jadi
Pengelolaan Sampel Terpisah